CDRH New Update

The following new items were added to the CDRH web pages on October 16, 2018. Previous CDRH New items can be found on the CDRH New webpage. CDRH Learn Modules: How to Get Your Electronic Product on the U.S. Market , 510(k) Third Party Review Program Overview, and X-Ray Systems  Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180026 added) FDA and DHS increase coordination of responses to medical device cybersecurity threats under new partnership; a part of the two agencies’ broader effort to protect patient safety Federal Register: Immunology and Microbiology Devices; Classification of Herpes Virus Nucleic Acid-Based Cutaneous and Mucocutaneous Lesion Panel Federal Register: Neurological Devices; Classification of External Upper Limb Tremor Stimulator